Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04807101
Other study ID # STU#: 00214212
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date April 5, 2021
Est. completion date July 10, 2023

Study information

Verified date October 2023
Source Greg S Cohen MD LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a noninferiority study designed to examine whether conscious sedation with midazolam alone results in efficacy and safety that is not inferior to the combination of midazolam and fentanyl. English-speaking patients ≥18 years old and ≤75 years old presenting for GI endoscopy planned with conscious sedation using midazolam and fentanyl, will be randomized 1:1 to single agent sedation with midazolam or combination sedation with midazolam and fentanyl. Participants will be blinded to the choice of sedation. Sedation quality and adverse events will be measured with a validated patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS) [Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203]. Endoscopic quality measures in the 2 study groups will be collected by retrospective chart review, as an additional metric to ensure the quality of the procedure is not compromised by the choice of sedation.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date July 10, 2023
Est. primary completion date July 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - English-speaking patients - Patients =18 years old and =75 years old - Outpatients presenting for EGD and/or colonoscopy planned with conscious sedation using midazolam and fentanyl - Patients presenting for endoscopic procedures with no GI fellow or trainee involvement in the procedure Exclusion Criteria: - Patients with an allergy or prior adverse event to either fentanyl or midazolam - Patients who have previously not tolerated endoscopy with conscious sedation and require monitored anesthesia care (MAC) - Adults unable to consent - Individuals who are not yet adults (infants, children, teenagers) - Pregnant women - Prisoners - Vulnerable populations, including cognitively impaired adults and adults who are otherwise unable to consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
midazolam alone
elimination of fentanyl from conscious sedation

Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Greg S Cohen MD LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Felt During the Procedure Level of discomfort during the procedure as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire [Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203]. The patient will answer the question "How much discomfort did you experience during the procedure?" A visual analog scale will be used ranging from 0 to 10 with higher numbers indicating more pain. 1 day
Primary Adequacy of Sedation Adequacy of sedation as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire [Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203]. The patient will answer the question "If having this procedure again in the future, how much sedation would you prefer to have?" A visual analog scale will be used ranging from -5 to 5, with lower numbers indicating a preference for less sedation in the future and higher numbers indicating a preference for more sedation in the future. 1 day
Secondary Patient Reported Nausea Patient reported nausea as assessed by a yes or no answer to the question "Do you have any nausea now?" 1 day
Secondary Adverse Events Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted 1 day
Secondary Cecal Intubation Rate cecal intubation rate for the 2 arms of the study will be assessed by retrospective chart review through study completion, an average of 1 year
Secondary Cecal Intubation Time time to reach the cecum for the 2 arms of the study will be assessed by retrospective chart review through study completion, an average of 1 year
Secondary Colonoscopy Withdrawal Time Colonoscopy withdrawal time for the 2 arms of the study will be assessed by retrospective chart review through study completion, an average of 1 year
Secondary Adenoma Detection Rate Adenoma detection rate for the 2 arms of the study will be assessed by retrospective chart review through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas